Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
|ClinicalTrials.gov Identifier: NCT01082211|
Recruitment Status : Active, not recruiting
First Posted : March 8, 2010
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: 3D-Conformal External Beam||Phase 2|
- To evaluate skin, breast, and chest wall adverse events occurring within 1 year after completion of 3D-conformal partial-breast re-irradiation following repeat breast-preserving surgery in patients with locally recurrent breast carcinoma.
- To evaluate the adverse events occurring after 1 year from the completion of re-irradiation and at any time.
- To evaluate in-breast control rate in patients treated with this regimen.
- To evaluate freedom-from-mastectomy rate in these patients.
- To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to document eradication of CTCs by locoregional therapy.
- To determine whether translational objective will correlate with eradication or presence of CTCs with in-breast recurrence and distant metastasis-free survival.
- To evaluate cosmesis as judged by the patient and independent evaluation.
- To evaluate distant metastasis-free survival, mastectomy-free survival, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks.
Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiotherapy for circulating tumor cells analysis.
Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiotherapy.
After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma|
|Study Start Date :||June 2010|
|Primary Completion Date :||November 2014|
Experimental: Partial Breast Re-Irradiation
Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
Radiation: 3D-Conformal External Beam
Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.
- Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events [ Time Frame: From the end of radiation to 1 year. ]To evaluate the rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events (AEs) occurring within 1 year from the completion of reirradiation. Based on a rate of 4% for these AEs, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible & started protocol treatment [tx]) will provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate is at least 13% & 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have tx-related AEs, then tx-related AE rate considered unacceptable.
- In-breast Recurrence [ Time Frame: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above.
- Freedom From Mastectomy [ Time Frame: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10.
- Rate of Circulating Tumor Cells [ Time Frame: Prior to the start of radiation and 3 weeks after last radiation treatment. ]
- Treatment-related Adverse Events Any Time [ Time Frame: From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis. ]AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from all reported adverse events definitely, probably, or possibly related to protocol treatment.
- Cosmesis [ Time Frame: After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years. ]
- Distant Metastasis-free Survival [ Time Frame: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years. ]Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence.
- Mastectomy-free Survival [ Time Frame: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method.
- Overall Survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method.
- Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation [ Time Frame: After 1 year from the end of radiation. ]AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082211
Hide Study Locations
|United States, Arizona|
|Arizona Center for Cancer Care - Peoria|
|Peoria, Arizona, United States, 85381|
|United States, California|
|Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center|
|Burbank, California, United States, 91505|
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|JFK Medical Center|
|Atlantis, Florida, United States, 33462|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Cancer Institute at St. John's Hospital|
|Springfield, Illinois, United States, 62702|
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|St. Agnes Hospital Cancer Center|
|Baltimore, Maryland, United States, 21229|
|Central Maryland Oncology Center|
|Columbia, Maryland, United States, 21044|
|Tate Cancer Center at Baltimore Washington Medical Center|
|Glen Burnie, Maryland, United States, 21061|
|United States, Massachusetts|
|Cape Cod Hospital|
|Hyannis, Massachusetts, United States, 02601|
|United States, Michigan|
|Saint Joseph Mercy Cancer Center|
|Ann Arbor, Michigan, United States, 48106-0995|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|Battle Creek Health System Cancer Care Center|
|Battle Creek, Michigan, United States, 49017|
|McLaren Cancer Institute|
|Flint, Michigan, United States, 48532|
|Butterworth Hospital at Spectrum Health|
|Grand Rapids, Michigan, United States, 49503|
|Lacks Cancer Center at Saint Mary's Health Care|
|Grand Rapids, Michigan, United States, 49503|
|Van Elslander Cancer Center at St. John Hospital and Medical Center|
|Grosse Pointe Woods, Michigan, United States, 48236|
|West Michigan Cancer Center|
|Kalamazoo, Michigan, United States, 49007-3731|
|William Beaumont Hospital - Royal Oak Campus|
|Royal Oak, Michigan, United States, 48073|
|Seton Cancer Institute at Saint Mary's - Saginaw|
|Saginaw, Michigan, United States, 48601|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis|
|Saint Louis, Missouri, United States, 63110|
|Barnes-Jewish West County Hospital|
|Saint Louis, Missouri, United States, 63141|
|United States, New Jersey|
|Memorial Sloan-Kettering Cancer Center - Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|St. Barnabas Medical Center Cancer Center|
|Livingston, New Jersey, United States, 07039|
|Monmouth Medical Center|
|Long Branch, New Jersey, United States, 07740-6395|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton|
|Marlton, New Jersey, United States, 08053|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|Sands Cancer Center|
|Canandaigua, New York, United States, 14424|
|Memorial Sloan-Kettering Cancer Center|
|Commack, New York, United States, 11725|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|Highland Hospital of Rochester|
|Rochester, New York, United States, 14620|
|University Radiation Oncology at Parkridge Hospital|
|Rochester, New York, United States, 14626|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Memorial Sloan-Kettering Cancer Center - Rockville Centre|
|Rockville Centre, New York, United States, 11570|
|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center|
|Sleepy Hollow, New York, United States, 10591|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|McDowell Cancer Center at Akron General Medical Center|
|Akron, Ohio, United States, 44307|
|Summa Center for Cancer Care at Akron City Hospital|
|Akron, Ohio, United States, 44309-2090|
|Barberton Citizens Hospital|
|Barberton, Ohio, United States, 44203|
|Charles M. Barrett Cancer Center at University Hospital|
|Cincinnati, Ohio, United States, 45267|
|Flower Hospital Cancer Center|
|Sylvania, Ohio, United States, 43560|
|United States, Pennsylvania|
|Rosenfeld Cancer Center at Abington Memorial Hospital|
|Abington, Pennsylvania, United States, 19001|
|Delaware County Regional Cancer Center at Delaware County Memorial Hospital|
|Drexel Hill, Pennsylvania, United States, 19026|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Albert Einstein Cancer Center|
|Philadelphia, Pennsylvania, United States, 19141|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|United States, South Dakota|
|Rapid City Regional Hospital|
|Rapid City, South Dakota, United States, 57701|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|United States, Wisconsin|
|Community Memorial Hospital Cancer Care Center|
|Menomonee Falls, Wisconsin, United States, 53051|
|Columbia Saint Mary's Hospital - Ozaukee|
|Mequon, Wisconsin, United States, 53097|
|Columbia-Saint Mary's Cancer Care Center|
|Milwaukee, Wisconsin, United States, 53211|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Cross Cancer Institute at University of Alberta|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Principal Investigator:||Douglas W. Arthur, MD||Massey Cancer Center|